Maryland Attorney General Douglas F. Gansler announced today
that the Consumer Protection Division, together with the
offices of Attorneys General from
29 other states, has entered into a settlement of Consumer Protection Act
claims against Bayer Corporation concerning Bayer’s alleged failure
to properly warn prescribers and patients of potential adverse side effects
from the prescription drug Baycol.

The consent order filed today in the Circuit Court for Baltimore
City requires Bayer to register most of its clinical studies and
then post the results at the end of each study. The judgment also
orders Bayer's future compliance with the law in the marketing,
sale, and promotion of its pharmaceutical and biological products,
and prohibits Bayer from making false and misleading claims relating
to any such product sold in the United States. In addition, Bayer
will pay a total of $8 million to the 30 participating states.

“Prescribers and patients need to know about adverse side effects of prescription
medications. This settlement will ensure that everyone has the necessary information
to make the best decision when prescribing and taking medication,” said
Attorney General Gansler.

Together with
the Consent Order, Attorney General Gansler’s
Consumer Protection Division filed a complaint alleging that Bayer
Corporation failed in its marketing to adequately disclose safety
risks associated with Baycol, a statin drug used to lower cholesterol
that was withdrawn from the market on August 7, 2001. All statins
carry a known risk of myopathy (a weakening of the muscles) and
rhabdomyolysis (a more serious muscular disease). Bayer learned
that the risk for Baycol was significantly higher compared to other
statins, particularly at higher doses and when combined with genfibrozil,
another cholesterol-lowering drug. The Division alleged that while
Bayer informed the U.S. Food and Drug Administration about these
adverse effects, Bayer failed to adequately warn prescribers and
consumers about them. Bayer denied any wrongdoing.